← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K961463 # HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 (K961463) _Heartport, Inc. · GCJ · Oct 8, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961463 ## Device Facts - **Applicant:** Heartport, Inc. - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Oct 8, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiac surgery procedures. The trocar cannula may also be used for suture organization. ## Device Story Device provides thoracic cavity access via intercostal spaces; facilitates insertion of endoscopic instruments, thoracoscopes, and accessory devices; enables suture organization. Used in cardiac surgery; operated by surgeons. Device integrates functions of multiple predicate trocars and suture guides into single unit. Compatible with Heartport Oval Light for surgical site illumination. Benefits include minimal to no rib retraction during endoscopic procedures. ## Clinical Evidence Bench testing (in vitro) evaluated compatibility with endoscopic instruments and suture organization. In vivo studies conducted to confirm performance. Results demonstrated device is safe, effective, and meets clinical requirements. ## Technological Characteristics Thoracic trocar cannula and obturator system. Materials are identical to predicate devices with established biocompatibility. Designed for intercostal access. Compatible with external illumination accessory (Oval Light). ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar - Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic - Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator - Snowden-Pencer - Reusable Thora-Port - Deknatel - Gabby-Frater Suture Guide ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Heartport™ Thoracic Surgical Trocars Appendices # APPENDIX A. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: **K961463** OCT - 8 1996 ## Applicant Information: Date Prepared: April 16, 1996 Name: Heartport, Inc. Address: 200 Chesapeake Drive Redwood City, CA 94063 Contact Person: Isabella Abati Phone Number: (415) 306-7900 Fax Number: (415) 306-7905 ## Device Information: Classification: Class II Trade Name: Heartport™ Thoracic Surgical Trocar Common Name: Trocars Classification Name: Trocars: Cardiovascular Devices - Trocar, 21 CFR 870.1390 ## Equivalent Devices: The Heartport Thoracic Surgical Trocars are substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices: 1. U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar 2. Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic 3. Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator 4. Snowden-Pencer - Reusable Thora-Port 5. Deknatel - Gabby-Frater Suture Guide Heartport, Inc. CONFIDENTIAL Page 20 {1} Heartport™ Thoracic Surgical Trocars Appendices # 510(k) Summary of Safety and Effectiveness (continued) ## Intended Use: Heartport Thoracic Surgical Trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. The Heartport Thoracic Trocar allows endoscopic instruments, thoracoscopes and accessory devices to be inserted and used during cardiac surgery procedures. The trocar cannula may also be used for suture organization. ## Comparison To Predicate Devices: The Heartport Thoracic Surgical Trocars are equivalent in intended use and operational characteristics to the following devices: (1) U.S. Surgical - Auto Suture Thoracoport 11.5 mm Disposable Trocar, (2) Origin Medsystems (a Guidant Corp.) - Surgical Trocar Thoracic, (3) Ethicon (a Johnson & Johnson co.) - Endopath Thoracic Trocar Sleeve with Rounded Tip Obturator, (4) Snowden-Pencer - Reusable Thora-Port and (5) Deknatel - Gabby-Frater Suture Guide. The Heartport Thoracic Surgical Trocars combine the same functions as the individual predicate devices into a single device. Heartport Thoracic Surgical Trocars may be used with the Heartport Oval Light accessory device to provide illumination to the surgical site. ## Non-Clinical Test Results: ### Performance The Heartport Thoracic Surgical Trocar was evaluated *in vitro* for performance including compatibility with endoscopic instruments and suture organization ability. In addition, the Thoracic Surgical Trocar was evaluated during *in vivo* studies. Performance testing demonstrated that the Heartport Surgical Thoracic Trocar was safe and effective, while meeting the anticipated clinical requirements for its intended use. ### Biocompatibility The materials used to fabricate the Heartport Thoracic Surgical Trocar and Oval Light are the same as, and in most cases identical to, the predicate devices. The materials used in the Heartport Thoracic Surgical Trocar and Oval Light have proven biocompatibility. ## Summary: Based on the intended use, product information, performance and biocompatibility data provided in this Notification, Heartport Thoracic Surgical Trocars have been shown to be substantially equivalent to currently marketed predicate devices. Heartport, Inc. CONFIDENTIAL Page 21 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961463](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K961463) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com